- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01837004
Cognitive Regulation Training and Exercise (CORTEX)
Cognitive Regulation Training and Exercise (CORTEX) Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Primary Aim 1: To determine the efficacy of pre-intervention cognitive training for improving exercise adherence and engagement. We hypothesize that class participation rates, physical activity counts, and self-reported exercise participation levels will be higher at 4 months for participants in the CORTEX condition relative to the Control condition. We also predict that pre-intervention training will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.
Primary Aim 2: To determine if integrated general and exercise-specific cognitive training improves facets of executive function and exercise-related efficacy judgments. We hypothesize that participants in the CORTEX condition will show faster reaction times and greater accuracy for trained and untrained-domain-relevant tasks, including dual task performance, reasoning, and thought-stopping at post-booster testing and 4-month follow-up. Furthermore, we hypothesize that CORTEX participants will show significantly higher levels of exercise efficacy judgments, and exhibit greater automaticity (faster reaction times) in making those judgments, at post-booster testing, 1 month and 4-month follow-up.
Secondary Aim 1: We will use longitudinal mediation analyses to examine mechanisms of change brought about by the cognitive training effects on exercise adherence and engagement. We hypothesize that changes in efficacy and use of self-regulatory strategies will mediate cognitive training effects on exercise adherence over 4-months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Illinois
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Urbana, Illinois, Stati Uniti, 61801
- University of Illinois
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- men and women
- between 45-64 years old at time of study
- physically inactive for the past 3 months
- have reliable access to internet
- do NOT own or play exergames (Xbox Kinect, Playstation Move, or Nintendo Wii) regularly
- do NOT engage in "brain-training" regularly
- are NOT enrolled in another exercise program or cognitive training study
- willing to be randomized
- able to participant in the full length of the 5-month study with no more than 2 consecutive weeks of vacation
Exclusion Criteria:
- <45 or >64 years of age at time of study
- physically active (i.e., planned 30-min walking or exercise >2 days/wk)
- do not have reliable access to internet
- own and/or play exergames regularly (e.g., 1 day/wk)
- engage in "brain-training" regularly (e.g., Sudoku or computer game-play 1 day/wk)
- enrolled in another exercise program or cognitive training study
- cognitive impairment as defined by TICS score <21
- depression as defined by Geriatric Depression Scale score >5
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: CORTEX
The CORTEX group will attend 10, 2-hour sessions for a period of four weeks prior to the initial exercise program start.
One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
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2-hour sessions for a period of four weeks prior to the initial exercise program start.
One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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exercise adherence
Lasso di tempo: 4 months (from exercise intervention baseline to 4-month post-test)
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4 months (from exercise intervention baseline to 4-month post-test)
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exercise program engagement
Lasso di tempo: 4 month period (exercise intervention start to end)
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4 month period (exercise intervention start to end)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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automaticity of exercise-related efficacy judgments
Lasso di tempo: 5-month period
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-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
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5-month period
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exercise-related self-efficacy
Lasso di tempo: 5-month period
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-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
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5-month period
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executive functioning
Lasso di tempo: 5-month period
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-trained and untrained domains of executive functioning (e.g., dual-task ability, inhibitory control, reasoning) and memory assessed via computer-based and pencil-paper tasks; collected at baseline, 1m, and 5m
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5-month period
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Sean P Mullen, Ph.D., University of Illinois at Urbana-Champaign
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1R21HL11341001A1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .